Beruflich Dokumente
Kultur Dokumente
FRAME FORMULATIONS
January, 2000
CONTENTS
PREAMBLE
DECLARATION FORM 1
DECLARATION FORM 2
DECLARATION FORM 3
UPDATE FORM
FRAME FORMULATIONS
FRAME FORMULATION NAME FRAME
FORMULATION
NUMBER :
1. SKIN CARE
2
2. HAIR PRODUCTS
3
HAIR COLOUR RESTORER .. 2.27
3. BATH PRODUCTS
FOOTBATH 3.5
4. SHAVING PRODUCTS
5. PERFUME
PERFUME (TOILET WATER, EAU DE TOILETTE AND EAU DE PARFUM) ... 5.1
6. ANTIPERSPIRANTS/DEODORANTS
4
ANTIPERSPIRANT LIQUID SQUEEZE PACK OR PUMP SPRAY 6.7
7. SOAP
8. ORAL HYGIENE
TOOTHPASTE 8.1
MOUTHWASH .. 8.2
9. SUN PRODUCTS
FOUNDATION . 10.1
5
LIPSTICK /LIP CREAM (INCLUDING CONCEALER STICKS/CREAM) . 10.7
MASCARA .. 10.16
13. MISCELLANEOUS
6
DEPILATORY . 13.2
January 2000
Frame formulations
7
2000/020 - MC
Page 1 of 5
EAPCCT / COLIPA
COSMETIC FRAME FORMULATIONS FOR
EU POISON CENTRES
- PREAMBLE -
The EU Cosmetics Directive specifies that Member States may require the
provision of safety information to the competent authority (in the majority of cases :
Poison Centres) for products marketed in the EU. The purpose of this is to enable
the correct medical treatment to be given promptly in the event of an accident, such
as a child consuming a cosmetic product.
Both industry and the European Association of Poison Centres and Clinical
Toxicologists (EAPCCT) were keen to introduce a simple system that is workable
and avoids the need to deal with unnecessary detailed paperwork. The concept of
Frame Formulations is based on a system developed jointly by the UK Cosmetic,
Toiletry and Perfumery Trade Association (CTPA) with the National Poisons
Information Service (London), which has been in use for many years.
The Frame Formulations detail the type of ingredients and their maximum
concentration for most cosmetic products on the European market. If a product
fits the Frame Formulation, then only basic information needs to be provided to
the competent authorities at national level, a list of which was published in the
Official Journal of the European Communities (N C36, 10.02.99).
The majority of cosmetic products represent a relatively low risk on ingestion. The
Frame Formulations system enables rapid identification of a cosmetic product
which is unlikely to result in serious effects to health, when ingested or used
inappropriately.
However, under the Frame Formulations system, some cosmetic products need to
be declared in detail or require additional information to be provided.
2000/020 - MC
Page 2 of 5
PRODUCT DECLARATION :
The following products are covered by Frame Formulations, but require additional
information to be stated in Declaration Form 2.
2. Antidandruff products
Should a product contain more than 0.5% xanthine derivatives, then the INCI
name and the exact concentration of the derivative(s) must be specified.
2000/020 - MC
Page 3 of 5
The INCI name and the concentration of each solvent must be specified for
Frame Formulations 2.12 and 2.13. A new declaration is required when the
concentration changes by more than 20% of the value declared previously.
The INCI name and the concentration of each solvent must be specified for
Frame Formulations 2.25 and 2.26. A new declaration is required when the
concentration changes by more than 20% of the value declared previously.
The INCI name and the concentration of each persulfate and of each solvent
must be specified for Frame Formulation 2.29. A new declaration is required
when either of these concentrations changes by more than 20% of the value
declared previously.
The INCI name and the concentration of each solvent must be specified for
Frame Formulation 11.3. A new declaration is required when the concentration of
at least one solvent changes by more than 20% of the value declared previously.
PLANT EXTRACTS
ADDITIONAL INGREDIENTS
Many Frame Formulations contain the item additional ingredients. This designation
covers chemicals which do not contribute significantly to the product formulation and
which do not exceed 10% of the formulation. Such chemicals must not contribute in a
significant way to the toxicity profile of the cosmetic product.
It is always the responsibility of the manufacturer to ensure that any cosmetic ingredient
covered by the item additional ingredients does not affect the overall toxicity of the
marketed product.
2000/020 - MC
Page 5 of 5
The EU Cosmetics Directive 76/768/EEC lays down the legal requirements for marketing
safe cosmetic products.
The Directive has existed since 1976 and it has been regularly updated.
Further details can be found in the text of the Cosmetics Directive. The updated version
is available from Colipa.
******
DECLARATION TO POISON CENTRES
FORM 1
Products covered by a Frame Formulation where no additional information is required
NOTE: This form is only suitable for products that comply with a Frame Formulation but do
not require any additional information to be provided, according to the Preamble.
COMPANY: _______________________________________________________________
MAIN CONTACT (Person from company or a company division; he/she must have access to
qualitative/quantitative composition of the products)
ADDITIONAL CONTACT
w ADDITIONAL COMMENTS:
________________________________________________________________________________
________________________________________________________________________________
w COMPANY: ___________________________________________________________________
MAIN CONTACT (Person from company or from a company division; he/she must have access to
qualitative/quantitative composition of the products)
ADDITIONAL CONTACT
w QUANTITATIVE AND QUALITATIVE FORMULATION (% w/w active matter and with pH indicative
value if relevant)
(Please attach to this form a sheet with the formulation, using as ingredient names
the INCI names applied for ingredient labelling.
All information supplied will be handled confidentially)
pH: ____
w COMPANY: ____________________________________________________________________
MAIN CONTACT (Person from company or from a company division; he/she must have access to
qualitative/quantitative composition of the products)
ADDITIONAL CONTACT
YES
YES
IS YOUR PRODUCT CONCERNED BY ONE OF THE FOLLOWING :
PRODUCTS LISTING ETHANOL AND/OR ISOPROPANOL IN THEIR FF : % weight must be specified, even if it is 0% (if below 2% it can be considered 0%)
ANTIDANDRUFF PRODUCTS : INCI name and concentr. of antidandruff agent(s) must be specified
PRODUCTS CONTAINING VITAMIN A AND DERIVATIVES : exact content (I.U./g) of vitamin A or of any of its derivatives must be specified, if it exceeds
7 000 I.U./g of product, or if the amount exceeds 300 000 I.U. for the whole product
PRODUCTS CONTAINING XANTHINE DERIVATIVES : INCI name and exact concentr. of derivative(s) must be specified, if the product contains more than
0.5% xanthine derivatives
PRODUCTS CONTAINING CATIONIC SURFACTANTS : concentr. of cationic surfactants must be specified if > 5%
HAIRSPRAY PRODUCTS CONTAINING SOLVENTS : INCI name and concentr. of solvent(s) must be specified for FF 2.12 and 2.13
PERMANENT AND SEMI-PERMANENT HAIR COLORANT PRODUCTS CONTAINING SOLVENTS : INCI name and concentr. of solvent(s) must be specified for
FF 2.25 and 2.26
HAIR BLEACHES CONTAINING PERSULFATES AND SOLVENTS : INCI name and concentr. of persulfate(s) and of solvent(s) must be specified for FF 2.29
PRODUCTS CONTAINING HYDROGEN PEROXIDE : concentr. of H2O2 must be specified for FF 2.17 (part 1), 2.19, 2.26 (part 2) and 2.29 (solution A)
NAIL VARNISH PRODUCTS CONTAINING SOLVENTS : INCI name and concentr. of solvent(s) must be specified for FF 11.3
TOOTHPASTES AND MOUTHWASHES CONTAINING FLUORIDE COMPOUNDS : % weight for fluorine must be specified, even if it is 0%, for FF 8.1 and 8.2
BATH SALTS/CUBES CONTAINING INORGANIC SODIUM SALTS : total concentr. of sodium salt(s) must be specified for FF 3.3
PRODUCTS WITH A PH LOWER THAN 3 OR HIGHER THAN 10 : pH must be specified
PRODUCTS CONTAINING ESSENTIAL OILS (INCLUDING CAMPHOR) : except for perfume FF, the name and the quantity of the essential oil (or of
an essential oil derivative) must be specified, if its level is higher than 0.5%
NO YES
Ingredients Maximum
levels (% w/w)
Parfum 5
Zinc oxide 3
Preservatives, antimicrobials 2
Aqua to 100
Ingredients Maximum
levels (% w/w)
UV filters 10
Preservatives, antimicrobials 2
Parfum 1
Aqua to 100
Frame Formulation Number: 1.3 - 2000
SKIN CREAM INCLUDING MOISTURISER CREAM
Ingredients Maximum
levels (% w/w)
Preservatives, antimicrobials 2
Parfum 1
Aqua to 100
Frame Formulation Number: 1.4 - 2000
MOISTURISING PUMP SPRAY
Ingredients Maximum
levels (% w/w)
Mineral oils 30
Parfum 5
Antioxidants 0.1
Frame Formulation Number: 1.5 - 2000
BODY OIL / FACIAL OIL
Ingredients Maximum
levels (% w/w)
Parfum 5
Ingredients Maximum
levels (% w/w)
UV filters 8
Preservatives, antimicrobials 2
Parfum 1
Cosmetic colorants 1
Aqua to 100
Frame Formulation Number: 1.7 - 2000
HAND CLEANSING GEL
Ingredients Maximum
levels (% w/w)
Parfum 2
Preservatives, antimicrobials 1
Aqua to 100
Frame Formulation Number: 1.8 - 2000
FACE LOTION
Ingredients Maximum
levels (% w/w)
Plant extracts 10
Zinc oxide 5
Potassium alum 4
Camphor 2
Preservatives, antimicrobials 2
Parfum 1.5
Cosmetic colorants 1
Aqua to 100
Frame Formulation Number: 1.9 - 2000
FACIAL WASH
Ingredients Maximum
levels (% w/w)
Preservatives, antimicrobials 2
Parfum 1
Cosmetic colorants 1
Aqua to 100
Frame Formulation Number: 1.10 - 2000
MAKE-UP REMOVER / EYE MAKE-UP REMOVER
Ingredients Maximum
levels (% w/w)
Silicones 50
Ingredients Maximum
levels (% w/w)
Preservatives, antimicrobials 2
Aqua to 100
Frame Formulation Number: 1.12 - 2000
FACE MASK
Ingredients Maximum
levels (% w/w)
Waxes (e.g. cera alba), oils (mineral and vegetable) and fats 90
Preservatives, antimicrobials 2
Parfum 1
Cosmetic colorants 1
Aqua to 100
Frame Formulation Number: 1.13 - 2000
CELL RENEWAL LOTIONS AND GELS
Ingredients Maximum
levels (% w/w)
UV filters 10
Preservatives, antimicrobials 1
Parfum 1
Aqua to 100
Frame Formulation Number: 1.14 - 2000
ENCAPSULATED TREATMENT PRODUCTS
Ingredients Maximum
levels (% w/w)
Ingredients Maximum
levels (% w/w)
Cosmetic colorants 1
Parfum 0.5
Aqua to 100
Frame Formulation Number: 1.16 - 2000
ANTISEPTIC FOAMING GEL / FEMININE CLEANSING GEL
Ingredients Maximum
levels (% w/w)
Preservatives, antimicrobials 2
Parfum 1
Cosmetic colorants 1
Aqua to 100
Frame Formulation Number: 2.1 - 2000
SHAMPOO - LIQUID AND CREAM
Ingredients Maximum
levels (% w/w)
Preservatives, antimicrobials 1
Aqua to 100
Frame Formulation Number: 2.2 - 2000
SOAP SHAMPOO
Ingredients Maximum
levels (% w/w)
Plant extracts 10
Essential oils 1
Frame Formulation Number: 2.3 - 2000
SHAMPOO PLUS CONDITIONING LOTION
Ingredients Maximum
levels (% w/w)
Preservatives, antimicrobials 1
Cosmetic colorants 1
Parfum 0.5
Aqua to 100
Frame Formulation Number: 2.4 - 2000
HAIR CONDITIONER
Ingredients Maximum
levels (% w/w)
Parfum 3
UV filters 1
Preservatives, antimicrobials 1
Cosmetic colorants 1
Aqua to 100
Frame Formulation Number: 2.5 - 2000
HAIR CONDITIONER (SILICONE BASED)
Ingredients Maximum
levels (% w/w)
Ingredients Maximum
levels (% w/w)
Oils and waxes (mineral and vegetable) (e.g. petrolatum, glyceryl stearate) 60
Parfum 1
Preservatives, antimicrobials 1
Aqua to 100
Frame Formulation Number: 2.7 - 2000
HAIR SHINE WAX OR BRILLIANTINE
Ingredients Maximum
levels (% w/w)
Parfum 3
Cosmetic colorants 1
Frame Formulation Number: 2.8 - 2000
HAIR LOTION
Ingredients Maximum
levels (% w/w)
PPG ethers 10
Parfum 3
Preservatives, antimicrobials 2
Camphor 0.5
Aqua to 100
Ingredients Maximum
levels (% w/w)
Acetone 10
Parfum 2
Ethoxylated glycols 2
Preservatives, antimicrobials 2
Cationic surfactants 1
Aqua to 100
Frame Formulation Number: 2.10 - 2000
HAIR SHINE / STYLING GEL
Ingredients Maximum
levels (% w/w)
Parfum 1
Cosmetic colorants 1
Aqua to 100
Frame Formulation Number: 2.11 - 2000
HAIR MOUSSE
Ingredients Maximum
levels (% w/w)
Polyglycol ethers 5
Preservatives, antimicrobials 2
Cosmetic colorants 1
Parfum 0.2
Aqua to 100
Frame Formulation Number: 2.12 - 2000
HAIR SPRAY - AEROSOL
Ingredients Maximum
levels (% w/w)
Preservatives, antimicrobials 1
Parfum 1
Aqua to 100
Frame Formulation Number: 2.13 - 2000
HAIR SPRAY - PUMP SPRAY
Ingredients Maximum
levels (% w/w)
Preservatives, antimicrobials 1
Parfum 1
Aqua to 100
Frame Formulation Number: 2.14 - 2000
PERMANENT WAVE LOTION - I
Ingredients Maximum
levels (% w/w)
Reducing agents:
- ammonium thioglycolate (professional use) 13 *
(general use) 9.5 *
- cysteine HCl 10
Diammonium dithiodiglycolate 6
Parfum 1
Cosmetic colorants 1
Aqua to 100
Ingredients Maximum
levels (% w/w)
Reducing agents:
- ammonium thioglycolate 9.5 *
- cysteine HCl 10
- other thioacid ammonium salts (e.g. ammonium thiolactate) 3
Parfum 1
Cosmetic colorants 1
Aqua to 100
Ingredients Maximum
levels (% w/w)
Reducing agents:
- ammonium thiolactate 12
- cysteine HCl 5
Parfum 1
Cosmetic colorants 1
Aqua to 100
pH value: 7 - 9.5
Frame Formula Number: 2.17 - 2000
PERMANENT WAVE LOTION - IV
Ingredients Maximum
levels (% w/w)
PART 1
Hydrogen peroxide 12
Non-ionic surfactants 5
Aqua to 100
PART 2
Ammonium thioglycolate 20 *
Parfum 1
Cosmetic colorants 1
Aqua to 100
Parts 1 and 2 are combined for use, the mixing of 1 and 2 is exothermic
pH value of combined ready-to-use mixture: 7 - 9.5
* after mixing : 11 % ammonium thioglycolate calculated as thioglycolic acid (professional
use)
8 % ammonium thioglycolate calculated as thioglycolic acid (general use)
Frame Formulation Number: 2.18 - 2000
PERMANENT WAVE LOTION - V
Ingredients Maximum
levels (% w/w)
PART 1
Glycerin 50
PART 2
Reducing agents:
- ammonium thioglycolate 5
- cysteine HCl 10
Diammonium dithiodiglycolate 4
Opacifying agents 1
Parfum 1
Aqua to 100
Ingredients Maximum
levels (% w/w)
Parfum 1
Cosmetic colorants 1
Aqua to 100
Frame Formulation Number: 2.20 - 2000
HAIR STRAIGHTENER (RELAXER) - I
Cream type based on lye
Ingredients Maximum
levels (% w/w)
Parfum 1
Aqua to 100
Ingredients Maximum
levels (% w/w)
CREAM BASE
Calcium hydroxide 10
Parfum 1
Aqua to 100
pH value: 11 - 13
ACTIVATOR
Guanidine carbonate 30
Parfum 1
Cosmetic colorants 1
Aqua to 100
pH value: 10 - 13
Mixed with cream base at the time of use to generate an alkaline mix of up to
5 % alkali calculated as calcium hydroxide.
pH value of cream base and activator mixed prior to use: 11 - 13.5
Frame Formulation Number: 2.22 - 2000
HAIR STRAIGHTENER (RELAXER) - III
Ingredients Maximum
levels (% w/w)
Parfum 1
Cosmetic colorants 1
Aqua to 100
pH value: 7 - 9.5
Frame Formulation Number: 2.23 - 2000
HAIR COLORANT (TEMPORARY) - SHAMPOO
Ingredients Maximum
levels (% w/w)
Parfum 1
Preservatives, antimicrobials 1
Aqua to 100
Frame Formulation Number: 2.24 - 2000
HAIR COLORANT (TEMPORARY) - MOUSSE AND LOTION
Ingredients Maximum
levels (% w/w)
Preservatives, antimicrobials 1
Aqua to 100
Ingredients Maximum
levels (% w/w)
Parfum 1
Preservatives, antimicrobials 1
Aqua to 100
NB: in two component products dyes or dye precursors are contained in one part, whilst
oxidising agents are in the other. Part I and Part II are mixed together immediately prior to use.
Ingredients Maximum
levels (% w/w)
PART I
Parfum 2
Aqua to 100
pH value: 8 - 11.5
Ingredients Maximum
levels (% w/w)
PART II
Hydrogen peroxide 12
Aqua to 100
Ingredients Maximum
levels (% w/w)
Sulfur 3
Parfum 1
Aqua to 100
Frame Formulation Number: 2.28 - 2000
DYE REMOVER (Reducing type)
Ingredients Maximum
levels (% w/w)
Aqua to 100
Aqua to 100
HAIR BLEACH
Ingredients Maximum
levels (% w/w)
POWDER (mixed with aqua for use alone or as activator for lotions)
Solution A
Hydrogen peroxide 12
Aqua to 100
Frame Formulation Number: 2.29 - 2000 page 2/2
HAIR BLEACH
Ingredients Maximum
levels (% w/w)
Solution B
Parfum 1
Aqua to 100
pH value solution B: 8 - 10
Ingredients Maximum
levels (% w/w)
Parfum 6
Cosmetic colorants 1
Preservatives, antimicrobials 1
Aqua 100
Frame Formulation Number: 3.2 - 2000
BATH MILK
Ingredients Maximum
levels (% w/w)
Parfum 5
Cosmetic colorants 1
Aqua to 100
Frame Formulation Number: 3.3 - 2000
BATH SALTS / CUBES
Ingredients Maximum
levels (% w/w)
Parfum 5
Cosmetic colorants 1
Ingredients Maximum
levels (% w/w)
Oils (e.g. mineral, zea mays) and emollients (e.g. glycerin, PEG,
isopropyl myristate, silicones) 90
Parfum 10
Cosmetic colorants 1
Antioxidants 0.1
Ingredients Maximum
levels (% w/w)
Parfum 1
Cosmetic colorants 1
Aqua to 100
Frame Formulation Number: 4.1 - 2000
SHAVING CREAM AND BRUSHLESS SHAVING CREAM
Ingredients Maximum
levels (% w/w)
SOAP BASED
Soaps (e.g. mixed sodium and potassium stearates, laurates and cocoates) 60
Humectants (e.g. glycerin, propylene glycol) 30
Viscosity controlling agents, emulsifying agents
(e.g. fatty acid glycol esters, fatty alcohols) 15
Emollients (e.g. lanolin derivatives, oils, fatty acid esters) 15
Silicones (e.g. dimethicone) 10
Synthetic surfactants (e.g. anionic such as sodium laureth sulfate) 5
Parfum 2
Additional ingredients (e.g. viscosity controlling agents, vitamins) 2
Opacifying agents (e.g. titanium dioxide) 1
Menthol 1
Anticorrosives (e.g. sodium metasilicate) 0.5
Sodium borate 0.5
Chelating agents 0.5
Antioxidants 0.1
Aqua to 100
BRUSHLESS
Fatty acids 40
Oils (e.g. mineral oil, lanolin oil) 20
Soaps (e.g. Tea-stearate and TEA-laurate) 10
Silicones (e.g. dimethicone) 10
Additional ingredients (e.g. vitamins, plant extracts) 2
Parfum 2
Antioxidants, chelating agents 0.5
Aqua to 100
Frame Formulation Number: 4.2 - 2000
SHAVE GEL
Ingredients Maximum
levels (% w/w)
Parfum 1
Cosmetic colorants 1
Preservatives, antimicrobials 1
Aqua to 100
Frame Formulation Number: 4.3 - 2000
SHAVING GEL (POST FOAMING)
Ingredients Maximum
levels (% w/w)
Soaps (e.g. potassium salts of fatty acids, triethanolamine salts of fatty acids) 30
Parfum 2
Cosmetic colorants 1
Menthol 0.2
Aqua to 100
Frame Formulation Number: 4.4 - 2000
SHAVING FOAM AEROSOL
Ingredients Maximum
levels (% w/w)
Parfum 1
Preservatives, antimicrobials 1
Menthol 0.5
Aqua to 100
Frame Formulation Number: 4.5 - 2000
SHAVING SOAP / STICK
Ingredients Maximum
levels (% w/w)
Parfum 2
Titanium dioxide 1
Preservatives, antimicrobials 1
Antioxidants 0.1
Menthol 0.1
Frame Formulation Number: 4.6 - 2000
AFTERSHAVE BALM
Ingredients Maximum
levels (% w/w)
Parfum 5
Cosmetic colorants 1
Preservatives, antimicrobials 1
Aqua to 100
Frame Formulation Number: 4.7 - 2000
AFTERSHAVE LOTION
Ingredients Maximum
levels (% w/w)
Parfum 10
Cosmetic colorants 1
Aqua to 100
Ingredients Maximum
levels (% w/w)
Parfum 40
UV filters 2
Cosmetic colorants 1
Antioxidants 0.1
Aqua to 100
Ingredients Maximum
levels (% w/w)
Parfum 3
Ingredients Maximum
levels (% w/w)
Parfum 3
Preservatives, antimicrobials 1
Aqua to 100
NB: includes aerosol spray compressed gas (e.g. air, nitrogen, carbon dioxide)
Frame Formulation Number: 6.3 - 2000
ANTIPERSPIRANT ROLL-ON
(with antiperspirant salt)
Ingredients Maximum
levels (% w/w)
Parfum 3
Aqua to 100
Frame Formulation Number: 6.4 - 2000
DEODORANT ROLL-ON
(without antiperspirant salt)
Ingredients Maximum
levels (% w/w)
Parfum 3
Aqua to 100
Frame Formulation Number: 6.5 - 2000
ANTIPERSPIRANT STICK
(with antiperspirant salt)
Ingredients Maximum
levels (% w/w)
Talc 15
Parfum 3
Preservatives, antimicrobials 1
Aqua to 100
Frame Formulation Number: 6.6 - 2000
DEODORANT STICK
(without antiperspirant salt)
Ingredients Maximum
levels (% w/w)
Talc 15
Parfum 3
Preservatives, antimicrobials 1
Aqua to 100
Frame Formulation Number: 6.7 - 2000
ANTIPERSPIRANT LIQUID SQUEEZE PACK OR PUMP SPRAY
Ingredients Maximum
levels (% w/w)
Parfum 3
Preservatives, antimicrobials 1
Aqua to 100
Frame Formulation Number: 6.8 - 2000
DEODORANT LIQUID SQUEEZE PACK OR PUMP SPRAY
Ingredients Maximum
levels (% w/w)
Parfum 3
Preservatives, antimicrobials 1
Aqua to 100
Frame Formulation Number: 6.9 - 2000
ANTIPERSPIRANT CREAM
Ingredients Maximum
levels (% w/w)
Parfum 3
Aqua to 100
Frame Formulation Number: 7.1 - 2000
SOAP - TOILET
Ingredients Maximum
levels (% w/w)
Soap (based on tallow, palm oil and coconut oil fatty acids) 99
Glycerin 20
Parfum 5
Titanium dioxide 2
Aqua to 100
Frame Formulation Number: 7.2 - 2000
LIQUID SOAP
Ingredients Maximum
levels (% w/w)
Parfum 2
Preservatives, antimicrobials 2
Cosmetic colorants 1
Aqua to 100
NB: liquid soaps may be soap based, totally synthetic based or a combination of both soap
and synthetic.
Frame Formulation Number: 8.1 - 2000
TOOTHPASTE
Ingredients Maximum
levels (% w/w)
Sorbitol 70
Abrasives (e.g. dicalcium phosphate dihydrate and/or alumina and/or
calcium carbonate and/or silica and silicates) 55
Glycerin 40
Insoluble metaphosphate (IMP) 35
Ethanol (alcohol, alcohol denat.) 30
Sodium pyrophosphate, potassium pyrophosphate 15
PEG, PPG 10
Oral care-protecting agents (e.g. strontium chloride) 10
Anionic surfactants (e.g. sodium lauryl sulfate) 6
Viscosity controlling agents (e.g. cellulose derivatives) 5
Additional ingredients (e.g. pH stabilisers such as sodium/potassium phosphate) 5
Flavour (mostly essential oils, e.g. mint) 3
Titanium dioxide 2
Cosmetic colorants 1
Oral care-antiplaque (e.g. zinc citrate, bromochlorophene) 1
Oral care-sweetening agents (e.g. saccharin) 0.5
Esters of hydroxybenzoic acid 0.4
Calcium glycerophosphate 0.15
Fluoride compounds (calculated as Fluorine) 0.15 *
Ingredients Maximum
levels (% w/w)
Cosmetic colorants 3
Preservatives, antimicrobials 1
Camphor 0.5
Aqua to 100
Ingredients Maximum
levels (% w/w)
Cosmetic colorants 3
Preservatives, antimicrobials 1
Aqua to 100
Frame Formulation Number: 8.4 - 2000
BREATH SPRAY
Ingredients Maximum
levels (% w/w)
Menthol 0.1
Aqua to 100
Frame Formulation Number: 9.1 - 2000
SUN TAN CREAM AND LOTION
Ingredients Maximum
levels (% w/w)
UV filters 15
Parfum 3
Preservatives, antimicrobials 2
Cosmetic colorants 1
Aqua to 100
Frame Formulation Number: 9.2 - 2000
SUN TAN OIL
Ingredients Maximum
levels (% w/w)
UV filters 15
Parfum 3
Preservatives, antimicrobials 1
Cosmetic colorants 1
Ingredients Maximum
levels (% w/w)
UV filters 15
Antioxidants 1
Ingredients Maximum
levels (% w/w)
UV filters 15
Parfum 1
Preservatives, antimicrobials 1
Cosmetic colorants 1
Aqua to 100
Frame Formulation Number: 9.5 - 2000
SUN TAN GEL (OIL BASED)
Ingredients Maximum
levels (% w/w)
UV filters 10
Cosmetic colorants 1
Parfum 1
Antioxidants 0.5
Ingredients Maximum
levels (% w/w)
UV filters 15
Dihydroxyacetone 6
Parfum 1
Aqua to 100
Frame Formulation Number: 9.7 - 2000
ARTIFICIAL TAN - GEL
Ingredients Maximum
levels (% w/w)
UV Filters 15
Dihydroxyacetone 6
Preservatives, antimicrobials 1
Cosmetic colorants 1
Parfum 0.5
Aqua to 100
Frame Formulation Number: 10.1 - 2000
FOUNDATION
Ingredients Maximum
levels (% w/w)
UV filters 5
Parfum 1
Preservatives, antimicrobials 1
Aqua to 100
Frame Formulation Number: 10.2 - 2000
FOUNDATION (ANHYDROUS)
Ingredients Maximum
levels (% w/w)
UV filters 5
Preservatives, antimicrobials 1
Parfum 1
Antioxidants 0.1
Frame Formulation Number: 10.3 - 2000
CONCEALER CREAM
Ingredients Maximum
levels (% w/w)
UV filters 3
Aqua to 100
Frame Formulation Number: 10.4 - 2000
CONCEALER STICK - I
Ingredients Maximum
levels (% w/w)
Aqua to 100
Frame Formulation Number: 10.5 - 2000
CONCEALER STICK - II
Ingredients Maximum
levels (% w/w)
UV filters 3
Frame Formulation Number: 10.6 - 2000
FACE POWDER
Ingredients Maximum
levels (% w/w)
Zinc oxide 20
Titanium dioxide 20
Binding agents, oils (e.g. mineral or vegetable oils, fatty acid esters, silicones) 20
Magnesium/calcium carbonates 10
UV Filters 5
Parfum 1.5
Frame Formulation Number: 10.7 - 2000
LIPSTICK CREAM (including concealer sticks/creams)
Ingredients Maximum
levels (% w/w)
Parfum 2
Flavouring agents 1
Aqua to 100
Frame Formulation Number: 10.8 - 2000
LIP COLOUR AND GLOSSER/BALM
Ingredients Maximum
levels (% w/w)
Parfum 2
Flavouring agents 1
Ingredients Maximum
levels (% w/w)
Parfum 0.5
Frame Formulation Number: 10.10 - 2000
LIPSTICK SEALER / LIP COAT
Ingredients Maximum
levels (% w/w)
Ingredients Maximum
levels (% w/w)
Preservatives, antimicrobials 1
Parfum 1
Aqua to 100
Frame Formulation Number: 10.12 - 2000
EYE SHADOW
Ingredients Maximum
levels (% w/w)
POWDER
Parfum 1
Preservatives, antimicrobials 1
STICK
Parfum 1
Ingredients Maximum
levels (% w/w)
CREAM
Ingredients Maximum
levels (% w/w)
Waxes, oils and fats (e.g. ozokerite, carnauba, hydrogenated vegetable oil) 70
UV filters 5
Parfum 0.3
Frame Formulation Number: 10.15 - 2000
EYE LINER
Ingredients Maximum
levels (% w/w)
Preservatives, antimicrobials 1
Parfum 1
Aqua to 100
CAKE
Parfum 1
Preservatives, antimicrobials 1
Frame Formulation Number: 10.16 - 2000 page 1/3
MASCARA
Ingredients Maximum
levels (% w/w)
REGULAR
Isoparaffins 5
Parfum 0.2
Aqua to 100
Frame Formulation Number: 10.16 - 2000 page 2/3
MASCARA
Ingredients Maximum
levels (% w/w)
WATERPROOF
Aqua 10
Parfum 1
Sodium borate 1
Antioxidants 1
Preservatives, antimicrobials 1
Frame Formulation Number: 10.16 - 2000 page 3/3
MASCARA
Ingredients Maximum
levels (% w/w)
CAKE
Aqua 20
Preservatives, antimicrobials 1
Frame Formulation Number: 11.1 - 2000
NAIL CONDITIONER (OIL BASED)
Ingredients Maximum
levels (% w/w)
Cosmetic colorants 1
Parfum 0.1
Ingredients Maximum
levels (% w/w)
Ingredients Maximum
levels (% w/w)
Camphor 5
UV filters 2
Frame Formulation Number: 12.1 - 2000
BABY LOTION - MILK
Ingredients Maximum
levels (% w/w)
Talc 5
Cosmetic colorants 1
Parfum 0.5
Aqua to 100
Frame Formulation Number: 12.2 - 2000
BABY CREAM
Ingredients Maximum
levels (% w/w)
Zinc oxide 20
Parfum 0.5
Aqua to 100
Frame Formulation Number: 12.3 - 2000
ZINC AND CASTOR OIL CREAM (Emulsion Based)
Ingredients Maximum
levels (% w/w)
Petrolatum 25
Zinc oxide 10
Castor oil 10
Aqua to 100
Frame Formulation Number: 12.4 - 2000
PETROLEUM JELLY
Ingredients Maximum
levels (% w/w)
Petrolatum 100
Parfum 0.5
Frame Formulation Number: 12.5 - 2000
BABY MOIST TISSUES
Ingredients Maximum
levels (% w/w)
Parfum 1.5
Preservatives, antimicrobials 1
Aqua to 100
Frame Formulation Number: 12.6 - 2000
BABY OIL AND WIPES
Ingredients Maximum
levels (% w/w)
Cosmetic colorants 1
Parfum 0.5
Antioxidants 0.5
Ingredients Maximum
levels (% w/w)
Talc 99
Kaolin 10
Parfum 10
Ingredients Maximum
levels (% w/w)
Parfum 1
Aqua to 100
Ingredients Maximum
levels (% w/w)
BLEACHING CREAM
Hydrogen peroxide 4
pH adjusters qs pH 2-3
Aqua to 100
Frame Formulation Number: 13.4 - 2000
BODY GLITTER
Ingredients Maximum
levels (% w/w)
Triethanolamine 2
Preservatives, antimicrobials 1
Surfactants 0.5
Aqua to 100
Frame Formulation Number: 13.5 - 2000
REFRESHING WET WIPES
Ingredients Maximum
levels (% w/w)
Parfum 2
Preservatives, antimicrobials 2
Aqua to 100
NB: Some baby wipes do contain ethanol (alcohol, alcohol denat.) at 10%
DECLARATION TO POISON CENTRES
FORM 1
Products covered by a Frame Formulation where no additional information is required
NOTE: This form is only suitable for products that comply with a Frame Formulation but do
not require any additional information to be provided, according to the Preamble.
COMPANY: _______________________________________________________________
MAIN CONTACT (Person from company or a company division; he/she must have access to
qualitative/quantitative composition of the products)
ADDITIONAL CONTACT
EAPCCT / COLIPA
COSMETIC FRAME FORMULATIONS FOR
EU POISON CENTRES
- PREAMBLE -
The EU Cosmetics Directive specifies that Member States may require the
provision of safety information to the competent authority (in the majority of cases :
Poison Centres) for products marketed in the EU. The purpose of this is to enable
the correct medical treatment to be given promptly in the event of an accident, such
as a child consuming a cosmetic product.
Both industry and the European Association of Poison Centres and Clinical
Toxicologists (EAPCCT) were keen to introduce a simple system that is workable
and avoids the need to deal with unnecessary detailed paperwork. The concept of
Frame Formulations is based on a system developed jointly by the UK Cosmetic,
Toiletry and Perfumery Trade Association (CTPA) with the National Poisons
Information Service (London), which has been in use for many years.
The Frame Formulations detail the type of ingredients and their maximum
concentration for most cosmetic products on the European market. If a product
fits the Frame Formulation, then only basic information needs to be provided to
the competent authorities at national level, a list of which was published in the
Official Journal of the European Communities (N C36, 10.02.99).
The majority of cosmetic products represent a relatively low risk on ingestion. The
Frame Formulations system enables rapid identification of a cosmetic product
which is unlikely to result in serious effects to health, when ingested or used
inappropriately.
However, under the Frame Formulations system, some cosmetic products need to
be declared in detail or require additional information to be provided.
2000/020 - MC
Page 2 of 5
PRODUCT DECLARATION :
The following products are covered by Frame Formulations, but require additional
information to be stated in Declaration Form 2.
2. Antidandruff products
Should a product contain more than 0.5% xanthine derivatives, then the INCI
name and the exact concentration of the derivative(s) must be specified.
2000/020 - MC
Page 3 of 5
The INCI name and the concentration of each solvent must be specified for
Frame Formulations 2.12 and 2.13. A new declaration is required when the
concentration changes by more than 20% of the value declared previously.
The INCI name and the concentration of each solvent must be specified for
Frame Formulations 2.25 and 2.26. A new declaration is required when the
concentration changes by more than 20% of the value declared previously.
The INCI name and the concentration of each persulfate and of each solvent
must be specified for Frame Formulation 2.29. A new declaration is required
when either of these concentrations changes by more than 20% of the value
declared previously.
The INCI name and the concentration of each solvent must be specified for
Frame Formulation 11.3. A new declaration is required when the concentration of
at least one solvent changes by more than 20% of the value declared previously.
PLANT EXTRACTS
ADDITIONAL INGREDIENTS
Many Frame Formulations contain the item additional ingredients. This designation
covers chemicals which do not contribute significantly to the product formulation and
which do not exceed 10% of the formulation. Such chemicals must not contribute in a
significant way to the toxicity profile of the cosmetic product.
It is always the responsibility of the manufacturer to ensure that any cosmetic ingredient
covered by the item additional ingredients does not affect the overall toxicity of the
marketed product.
2000/020 - MC
Page 5 of 5
The EU Cosmetics Directive 76/768/EEC lays down the legal requirements for marketing
safe cosmetic products.
The Directive has existed since 1976 and it has been regularly updated.
Further details can be found in the text of the Cosmetics Directive. The updated version
is available from Colipa.
******
DECLARATION TO POISON CENTRES
FORM 1
Products covered by a Frame Formulation where no additional information is required
NOTE: This form is only suitable for products that comply with a Frame Formulation but do
not require any additional information to be provided, according to the Preamble.
COMPANY: _______________________________________________________________
MAIN CONTACT (Person from company or a company division; he/she must have access to
qualitative/quantitative composition of the products)
ADDITIONAL CONTACT
w ADDITIONAL COMMENTS:
________________________________________________________________________________
________________________________________________________________________________
w COMPANY: ___________________________________________________________________
MAIN CONTACT (Person from company or from a company division; he/she must have access to
qualitative/quantitative composition of the products)
ADDITIONAL CONTACT
w QUANTITATIVE AND QUALITATIVE FORMULATION (% w/w active matter and with pH indicative
value if relevant)
(Please attach to this form a sheet with the formulation, using as ingredient names
the INCI names applied for ingredient labelling.
All information supplied will be handled confidentially)
pH: ____
w COMPANY: ____________________________________________________________________
MAIN CONTACT (Person from company or from a company division; he/she must have access to
qualitative/quantitative composition of the products)
ADDITIONAL CONTACT
YES
YES
IS YOUR PRODUCT CONCERNED BY ONE OF THE FOLLOWING :
PRODUCTS LISTING ETHANOL AND/OR ISOPROPANOL IN THEIR FF : % weight must be specified, even if it is 0% (if below 2% it can be considered 0%)
ANTIDANDRUFF PRODUCTS : INCI name and concentr. of antidandruff agent(s) must be specified
PRODUCTS CONTAINING VITAMIN A AND DERIVATIVES : exact content (I.U./g) of vitamin A or of any of its derivatives must be specified, if it exceeds
7 000 I.U./g of product, or if the amount exceeds 300 000 I.U. for the whole product
PRODUCTS CONTAINING XANTHINE DERIVATIVES : INCI name and exact concentr. of derivative(s) must be specified, if the product contains more than
0.5% xanthine derivatives
PRODUCTS CONTAINING CATIONIC SURFACTANTS : concentr. of cationic surfactants must be specified if > 5%
HAIRSPRAY PRODUCTS CONTAINING SOLVENTS : INCI name and concentr. of solvent(s) must be specified for FF 2.12 and 2.13
PERMANENT AND SEMI-PERMANENT HAIR COLORANT PRODUCTS CONTAINING SOLVENTS : INCI name and concentr. of solvent(s) must be specified for
FF 2.25 and 2.26
HAIR BLEACHES CONTAINING PERSULFATES AND SOLVENTS : INCI name and concentr. of persulfate(s) and of solvent(s) must be specified for FF 2.29
PRODUCTS CONTAINING HYDROGEN PEROXIDE : concentr. of H2O2 must be specified for FF 2.17 (part 1), 2.19, 2.26 (part 2) and 2.29 (solution A)
NAIL VARNISH PRODUCTS CONTAINING SOLVENTS : INCI name and concentr. of solvent(s) must be specified for FF 11.3
TOOTHPASTES AND MOUTHWASHES CONTAINING FLUORIDE COMPOUNDS : % weight for fluorine must be specified, even if it is 0%, for FF 8.1 and 8.2
BATH SALTS/CUBES CONTAINING INORGANIC SODIUM SALTS : total concentr. of sodium salt(s) must be specified for FF 3.3
PRODUCTS WITH A PH LOWER THAN 3 OR HIGHER THAN 10 : pH must be specified
PRODUCTS CONTAINING ESSENTIAL OILS (INCLUDING CAMPHOR) : except for perfume FF, the name and the quantity of the essential oil (or of
an essential oil derivative) must be specified, if its level is higher than 0.5%
NO YES